Method of making a hand access laparoscopic device

ABSTRACT

The invention relates to a hand access laparoscopy device having a gelcap, a retainer, a sleeve and a retention ring. The gelcap includes gel that is bonded to a cap. The cap includes an inner cylindrical wall to which the gel in bonded, thereby providing a sealing area between the device and the wound in a body wall. By securing the gel to the inner cylindrical wall, the thickness of the gel and corresponding cap is minimized along with the overall footprint of the device. With the gel thickness reduced and able to be substantially flush, the “doming” phenomenon produced by insufflation of a patient&#39;s abdomen is reduced.

BACKGROUND OF THE INVENTION

This invention relates substantially to devices and other apparatusesfacilitating sealed access with surgical instruments, such as asurgeon's hand, across a body wall and into a body cavity.

In several areas of surgery there exists a need to have mechanisms ordevices that can seal a body cavity or space, and yet permit theintroduction of surgical instruments such as guidewires, endoscopes, andeven the hand of a surgeon. Typical of these areas of surgery islaparoscopic surgery that relies on surgical instruments insertedthrough the abdominal wall to reach an operative site within theabdominal cavity. In order to increase space around the operative sitewithin the cavity, insufflation gases are typically introduced toinflate the cavity and elevate the abdominal wall. This pressurizing ofthe abdominal cavity is referred to as pneumoperitoneum. In thiscontext, the need to seal the body cavity or space arises from the needto maintain the pneumoperitoneum even when instruments are present.

Trocars have been commonly used to provide instrument access inlaparoscopic surgeries. These trocars have included elaborate sealstructures having zero seals that prevent escape of the gases in theabsence of instruments, and instrument seals that prevent escape of thegases in the presence of instruments Unfortunately, the instrument sealshave been able to accommodate only a narrow range of instrumentdiameters Multiple seal pairs had to be provided where wider ranges weredesired.

Some instruments, such as the hand of the surgeon, have been too largefor trocar access Under these circumstances, hand-assisted laparoscopicseals have been provided. Such devices have been large, cumbersome, andlargely ineffective in providing the required sealing mechanism. Otheraccess devices, such as Touhy-Borst seals, have been used, but only forvery small diameter access such as that required by a guidewire.

Each of the prior devices suffers from drawbacks that make the devicedifficult or cumbersome to use. For example, a Touhy-Borst seal requirestwo hands to use and does not form a seal when a guidewire or otherdevice is about to be introduced. Present trocar seals and hand-assistedseals require two valves, one forming an instrument seal in the presenceof the instrument, and the other forming a zero seal in the absence ofthe instrument. For example, in hand-assisted devices, elaboratemechanisms have been required to seal around the surgeon's arm. When thearm is removed, a separate zero seal has been required to prevent theescape of blood or insufflation gases.

SUMMARY

The invention is directed to a method of making a gelcap portion of asurgical access device that is adapted for disposition relative to anincision in a body wall. The method includes providing an annular caphaving an opening therethrough, providing a casting mold having a moldcavity, providing a solvent, providing a polymer ofstyrene-ethylene/butylene-styrene having a styrene to rubber ratio of33/67, mixing the solvent and polymer to form a slurry of about 90% byweight solvent and about 10% by weight polymer, degassing the slurry ina vacuum chamber, filling the mold cavity with slurry, heating theslurry and the mold until the slurry attains a temperature within arange between about 130° C. and about 250° C. and maintaining the moldand slurry within the range until the slurry transforms into gel,cooling the gel to about ambient room temperature, and removing thecured gel from the mold.

In one aspect, the providing a solvent step includes providing mineraloil In another aspect, the degassing step includes applying a vacuum ofabout 0.79 meter of mercury to the slurry. In another aspect, thedegassing step includes stirring the slurry while degassing the slurry.In another aspect, the method also includes degassing the slurry whilethe slurry is in the mold. In another aspect, the method also includespreheating the slurry prior to filling the mold cavity with slurry. Inanother aspect, the cooling step includes immersing the gel in water Inanother aspect, the cooling step includes air cooling the gel. Inanother aspect, the method also includes inserting a plurality ofgas-filled balloons into the slurry in the mold cavity. In anotheraspect, the inserting step includes inserting the balloons into theslurry substantially around the center of the mold cavity. In anotheraspect, the inserting step includes dispersing the balloons in theslurry randomly about the mold cavity throughout the region beyond thecenter of the mold cavity. In another aspect, the method also includesinserting a plurality of solid objects into the slurry in the moldcavity and removing the plurality of solid objects after the gel iscured. In another aspect, the inserting step includes inserting spheresinto the slurry around the center of the mold cavity. In another aspect,the inserting step includes inserting the solid objects in the slurrysubstantially around the center of the mold cavity. In another aspect,the inserting step includes dispersing the solid objects in the slurryrandomly about the mold cavity throughout the region beyond the centerof the mold cavity. In another aspect, the method also includessterilizing the gelcap with gamma sterilization In another aspect, themethod also includes mixing the slurry in a centrifuge while heating theslurry and the mold In another aspect, the method also includes couplingthe gel to the cap. In another aspect, the coupling step includesbonding the gel to the cap with cyanoacrylate In another aspect, theproviding a cap step includes providing a cap made of a plasticmaterial. In another aspect, the coupling step includes applying asolvent to the gel to melt the polystyrene in the gel, applying asolvent to the cap to melt the plastic of the cap, and placing the gelin contact with the cap to allow a chemical bond to form between the geland the cap In another aspect, the providing a cap step includesproviding a cap having an inner cylindrical wall with the opening of thecap being defined by the inner cylindrical wall and the cap being madeof a polymeric material. The coupling step includes coupling the curedgel to the inner cylindrical wall of the cap In another aspect, theproviding a casting mold step includes providing a mold that isconfigured to produce a gel slug having a smaller periphery than theinner cylindrical wall of the cap and a height higher than the height ofthe inner cylindrical wall of the cap. In another aspect, the methodalso includes placing the gel slug within the inner cylindrical wall ofthe cap In another aspect, the coupling step includes compressionmolding the gel slug to the inner cylindrical wall of the cap In anotheraspect, the coupling step includes heating the gel slug and the cap to atemperature sufficient for the polystyrene of the gel and the polymer ofthe cap to form bonds with each other. In another aspect, the methodalso includes placing the cap into the mold cavity The filling stepincludes filling the mold cavity having the cap with slurry such thatthe slurry is in contact with the cap. The heating step includes heatingthe slurry, the cap and the mold until the slurry transforms into gel.The gel being coupled to the cap forms a gelcap The cooling stepincludes cooling the gelcap. The removing step includes removing thegelcap from the mold. In another aspect, the providing a cap stepincludes providing a cap including styrene-ethylene/butylene-styrene,and the heating step includes heating the slurry, cap and mold to aboveabout 1300C and maintaining the temperature above about 130° C. until abond is formed between the cap and mold. In another aspect, theproviding a cap step includes providing a cap including polycarbonate,and the heating step includes heating the slurry, cap and mold to about150° C. and maintaining that temperature until a bond is formed betweenthe cap and mold.

These and other features of the invention will become more apparent witha discussion of the various embodiments in reference to the associateddrawings.

DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a top perspective view of a hand access laparoscopicdevice of the present invention;

FIG. 2 depicts a bottom perspective view of the hand access laparoscopicdevice of FIG. 1;

FIG. 3 depicts a plan view of a gelcap with a gel pad having regions ofvarying firmness;

FIG. 4 depicts a side view of a gelcap with gel having gas-filledpockets disbursed therein;

FIG. 5 depicts a plan view of a gelcap with gel having gas-filledpockets disbursed therein;

FIG. 6 depicts a plan view of a gelcap with gel having gas-filledpockets disbursed therein;

FIG. 7 depicts a side view of a hand access laparoscopic deviceincluding a gelcap with gel having gas-filled pockets disbursed therein;

FIG. 8 depicts a top perspective view of a multiple-piece cap havingsqueeze release buckle connectors molded into the ends of the piecesforming the cap;

FIG. 9 depicts a top perspective view of one of the pieces of the caphaving a male squeeze release buckle connector fitting at one end and afemale squeeze release buckle connector fitting at the other end;

FIG. 10 depicts a top perspective view of a cap having a gap with alatch pivotally coupled on one side of the gap and a groove foraccepting the latch on the other side of the gap;

FIG. 11 depicts a top perspective view of a cap having latches forreleasable coupling the cap to a retainer;

FIG. 12 depicts a side view of the cap of FIG. 11;

FIG. 13 depicts a top perspective view of a hand access laparoscopicdevice of the present invention including a cap and a retainer, theretainer having a plurality of snaps for releasably coupling theretainer to the cap;

FIG. 14 depicts a top perspective view of the cap of FIG. 13;

FIG. 15 depicts a top perspective view of the retainer of FIG. 13;

FIG. 16 depicts a section view depicting the interaction between the capand the retainer of FIG. 13;

FIG. 17 depicts a top perspective view of a hand access laparoscopicdevice of the present invention including a cap and a retainer, the caphaving a plurality of snaps for releasably coupling the cap to theretainer;

FIG. 18 depicts a top perspective view of the cap of FIG. 17;

FIG. 19 depicts a top perspective view of the retainer of FIG. 17;

FIG. 20 depicts a section view depicting the interaction between the capand the retainer of FIG. 17;

FIG. 21 depicts a side view of a hand access laparoscopic device havinga gelcap, a retainer, a sleeve and a retention ring, with a plurality ofstabilizers in the form of strings or tethers extending from theretention ring to the gelcap;

FIG. 22 depicts a side view of a hand access laparoscopic device havinga gelcap, a retainer, a sleeve and a retention ring, with a plurality ofstabilizers in the form of gussets or webs extending from the retentionring to the gelcap;

FIG. 23 depicts a top perspective view of a hand access laparoscopicdevice having a gelcap, a retainer, a sleeve and a retention ring, witha fabric integrated on the surface of the gel pad;

FIG. 24 depicts a partial side view of the hand access laparoscopicdevice of FIG. 23;

FIG. 25 depicts a top perspective view of a hand access laparoscopicdevice having a gelcap, a retainer, a sleeve and a retention ring, thegelcap having a cavity defined by fabric with the gel pad housed withinthe cavity; and

FIG. 26 depicts a bottom perspective view of a hand access laparoscopicdevice having a gelcap, a retainer, a sleeve and a retention ring, withthe gel pad having multi-cusped lobes that seal upon one another.

DESCRIPTION

In FIGS. 1 and 2, a surgical hand access device 50 according to oneaspect of the present invention is shown. The device includes a retainer52 and a cap 54. The cap 54 and the retainer 52 are both substantiallyannular and both include an opening therethrough The retainer 52 isadapted to be placed against a body wall. The retainer 52, in oneaspect, is rigid and is associated with and/or capable of being coupledto an elongate sleeve 56 The surgical hand access device 50 is adaptedfor disposition relative to an incision in a body wall. The surgicalhand access device 50 also facilitates insertion of an instrumentthrough the access device and maintenance of a sealing relationship withthe instrument.

In one aspect, the elongate sleeve 56 extends through an incision to apoint where an attached retention ring 58 contacts the interior portionsof the body cavity and provides tension between the retainer 52 outsidethe body cavity and the retention ring The retainer 52 in one aspectalso supports or otherwise enables a portion of the elongate sleeve 56to remain outside of the body cavity. Additionally, the retainer 52,retention ring 58 and elongate sleeve 56 together allow the incision tobe retracted and isolated during a surgical procedure. In one aspect,the elongate sleeve 56 and aspects thereof is a wound retractor typedevice such as described in U.S. patent application Ser. No. 10/516,198,filed Nov. 30, 2004, the disclosure of which is hereby incorporated byreference as if set forth in full herein.

As shown, the retainer 52 and retention ring 58 are circular, but as oneskilled in the art would appreciate, they may be of different shapes andsizes. The retainer 52 in one aspect may be either rigid, flexible or acombination of both The retention ring 58 may be flexible to facilitateinsertion into the body cavity As will be described in more detail, theaccess device 50 includes coupling means that are adapted for couplingthe cap 54 and the retainer 52 together.

A gel pad 60 may be coupled to, attached to, formed or integrated withthe cap 54 so that a gas-tight conduit is formed between the cap and thesleeve 56. The gel pad 60 covers and seals the entire opening in the cap54. In one aspect, the gel pad includes a plurality of intersectingdead-end slits 62, 64 that form an access portion or passage through thegel pad 60. Unlike foam rubber or other similar types of elasticmaterials, the gel pad 60 provides a gas tight seal around a variety ofshapes and sizes of hands or instruments inserted therethrough.

In one aspect, the gel material from which the gel pad 60 is made is anelastomeric gel. Some such gels have been described in U.S. patentapplication Ser. No. 10/381,220, filed Mar. 20, 2003, the disclosure ofwhich is hereby incorporated by reference as if set forth in fullherein. The gel can be prepared by mixing a triblock copolymer with asolvent for the midblocks. The endblocks are typically thermoplasticmaterials such as styrene and the midblocks are thermoset elastomerssuch as isoprene or butadiene, e.g., Styrene-Ethylene-Butylene-Styrene(SEBS). In one aspect, the solvent used is mineral oil Upon heating thismixture or slurry, the midblocks are dissolved into the mineral oil anda network of the insoluble endblocks forms. The resulting network hasenhanced elastomeric properties over the parent copolymer. In oneaspect, the triblock copolymer used is KRATON G1651, which has a styreneto rubber ratio of 33/67. Once formed, the gel is substantiallypermanent and, by the nature of the endblocks, processable asthermoplastic elastomers henceforward. The mixture or slurry has aminimum temperature at which it becomes a gel, i.e., the minimum gellingtemperature (MGT). This temperature, in one aspect, corresponds to theglass transition temperature of the thermoplastic endblock plus a fewdegrees. For example, the MGT for the mixture of KRATON G1651 andmineral oil is about 120° C. When the slurry reaches the MGT and thetransformation to a gel state takes place, the gel becomes moretransparent, thereby providing means for visually confirming when thetransformation of the slurry to the gel state is substantially completeand that the gel may be cooled. In addition to triblocks, there are alsodiblock versions of the materials that may be used where Styrene ispresent at only one end of the formula, for example,Styrene-Ethylene/Butylene (SEB).

For a given mass of slurry to form into a complete gel, the entire massof the slurry is heated to the MGT and remains heated at the MGT forsufficient time for the end blocks to form a matrix of interconnectionsThe slurry will continue to form into gel at temperatures above the MGTuntil the slurry/gel reaches temperatures at which the components withinthe slurry/gel begin to decompose or oxidize. For example, when theslurry/gel is heated at temperatures above 250° C., the mineral oil inthe slurry/gel will begin to be volatile and oxidize Oxidizing may causethe gel to turn brown and become oily.

The speed at which a given volume of slurry forms a gel is dependant onthe speed with which the entire mass of slurry reaches the MGT. Also,with the application of temperatures higher than the MGT, this speed isfurther enhanced as the end block networks distribute and form morerapidly.

The various base formulas may also be alloyed with one another toachieve a variety of intermediate properties. For example, KRATON G1701Xis a 70% SEB 30% SEBS mixture with an overall Styrene to rubber ratio of28/72. It can be appreciated that an almost infinite number ofcombinations, alloys, and Styrene to rubber ratios can be formulated,each capable of providing advantages to a particular embodiment of theinvention. These advantages will typically include low durometer, highelongation, and good tear strength.

It is contemplated that the gel material may also include silicone, softurethanes and even harder plastics that might provide the desiredsealing qualities with the addition of a foaming agent. The siliconematerial may be of the types currently used for electronicencapsulation. The harder plastics may include PVC, Isoprene, KRATONneat, and other KRATON/oil mixtures. In the KRATON/oil mixture, oilssuch as vegetable oils, petroleum oils and silicone oils may besubstituted for the mineral oil.

Any of the gel materials contemplated could be modified to achievedifferent properties such as enhanced lubricity, appearance, and woundprotection. Additives may be incorporated directly into the gel orapplied as a surface treatment. Other compounds may be added to the gelto modify its physical properties or to assist in subsequentmodification of the surface by providing bonding sites or a surfacecharge. Additionally, oil based colorants may be added to the slurry tocreate gels of different colors.

In one aspect, the mixture/slurry used with the various embodiments ofthe caps that are described herein are composed of about 90% by weightof mineral oil and about 10% by weight of KRATON G1651. From athermodynamic standpoint, this mixture behaves similar to mineral oil.Mineral oil has a considerable heat capacity and, therefore, at about130° C. it can take 3 or 4 hours to heat a pound of the slurrysufficiently to form a homogeneous gel. Once formed, the gel can becooled as quickly as practical with no apparent deleterious effects onthe gel This cooling, in one aspect, is accomplished with cold-waterimmersion. In another aspect, the gel may be air-cooled Those familiarwith the art will recognize that other cooling techniques that are wellknown in the art may be employed and are contemplated as within thescope of the present invention.

Many of the properties of the KRATON/oil mixture will vary withadjustments in the weight ratio of the components. In general, thegreater the percentage of mineral oil the less firm the mixture; thegreater the percentage of KRATON, the more firm the mixture If theresultant gel is too soft it can lead to excessive tenting or doming ofthe gelcap during surgery when a patient's abdominal cavity isinsufflated. Excessive tenting or doming may cause the slits 62, 64 toopen, providing a leak path. Additionally, if the gel is too soft itmight not provide an adequate seal. However, the gel should besufficiently soft to be comfortable for the surgeon while simultaneouslyproviding good sealing both in the presence of an instrument and in theabsence of an instrument.

If the slurry is permitted to sit for a prolonged period of time, thecopolymer, such as KRATON, and the solvent, such as mineral oil, mayseparate. The slurry may be mixed, such as with high shear blades, tomake the slurry more homogeneous However, mixing the slurry mayintroduce or add air to the slurry. To remove air from the slurry, theslurry may be degassed. In one aspect, the slurry may be degassed in avacuum, such as within a vacuum chamber. In one aspect, the appliedvacuum may be 0.79 meters (29.9 inches) of mercury, or about 1.0atmosphere. The slurry may be stirred while the slurry is under vacuumto facilitate removal of the air. During degassing within a vacuum, theslurry typically expands, then bubbles, and then reduces in volume Thevacuum may be discontinued when the bubbling substantially ceases.Degassing the slurry in a vacuum chamber reduces the volume of theslurry by about 10% Degassing the slurry helps reduce the potential ofthe finished gel to oxidize.

Degassing the slurry tends to make the resultant gel firmer. A degassedslurry composed of about 91.6% by weight of mineral oil and about 8.4%by weight of KRATON G1651, an eleven-to-one ratio, results in a gelhaving about the same firmness as a gel made from a slurry that is notdegassed and that is composed of about 90% by weight of mineral oil andabout 10% by weight of KRATON G1651, a nine-to-one ratio.

Mineral oil is of a lighter density than KRATON and the two componentswill separate after mixing, with the lighter mineral oil rising to thetop of the container. This separation may occur when attempting to formstatic slurry into gel over a period of several hours. The separationcan cause the resulting gel to have a higher concentration of mineraloil at the top and a lower concentration at the bottom, e.g., anon-homogeneous gel. The speed of separation is a function of the depthor head height of the slurry being heated. The mass of slurry combinedwith the head height, the temperature at which the gel sets and thespeed with which the energy can be transferred to the gel, factor intothe determination or result of homogeneous gel versus a non-homogeneousgel.

One aspect of a cap 70 in accordance with the present invention isillustrated in FIG. 3 with a gel pad 72 that differs in texture inspecific regions 74-80 For example, in one aspect, the gel pad 72 has asoft occlusive first, central sealing region 74, a second region 76 lessresilient than the first region, a third region 78 less resilient thanthe second region, a fourth region 80 less resilient than the thirdregion, and so-on More particularly, the gel pad 72 may include morethan two concentric regions having differing resiliency with theresiliency of each region decreasing in relation to the increase indistance from the first, central region 74. The progressively lessresilient or pliable regions allow positive attachment of the gel pad 72to a support structure, such as the cap 70, while preserving thedesirable occlusive properties of a softer more resilient material at,or about, the central portion of the gel pad.

In one aspect, the gel pad 72 has gradient concentric portions 74-80 inwhich the gel pad is centrifugally molded or formed. During gelformation, the slurry is mixed in a centrifuge. By rotating the slurrywhile forming the gel pad 72, density separation is created in whichdenser triblocks of the slurry migrate towards the circumference of thecontainer holding the spinning slurry and the mineral oil increases inconcentration towards the center. In this manner, a firmer gel is formedon the exterior of the finished part and a softer gel is formed in thecentral portion of the finished part, which is useful in hand accessseals for laparoscopic surgery.

In one aspect, a long flat rectangular part is used instead of a thincircular part There are three conventional axes of rotation associatedwith the rectangular part. The first axis is through the center of thepart normal to the long and short axes of the part Rotation about thefirst axis induces a higher density gel at the ends of the part as willrotating the gel about the short midpoint of the rectangle. However,rotation about the long axis of the rectangle creates higher density gelalong the long edges of the rectangle. The rotation can be alteredduring processing, as in the case of rotational molding, in which thepart is rotated about multiple axes during processing. The axis ofrotation does not have to intersect a centroid of the part or even bewithin the part itself.

A reverse texture layout of the gel pad 70 can be achieved by selectinglighter density triblocks and higher density mineral oils. Othercomponents can be added as well, based on the desired effect, includingadditives such as colorants, inert filler material, different oils,different triblock or diblock copolymers, polymers, plasticizers,decorative items, etc.

In one aspect, heavy plastic components 82 are provided with the gel pad72 or slurry and gravitate toward outer regions of the gel away from thecenter, leaving the central region 74 with a particular proportion ofplastic material and oil. The outer regions 76-80 of the gel pad 72 aredenser and contain more heavy plastic material than the central region74. When the particular gradient proportions for the gel pad 72 areachieved, rotation is slowed and the gel pad is allowed to cool.

In one aspect, a non-homogenous gel pad with soft gel on one side and afirmer gel on the other is accomplished with density separation overtime commensurate with the timing of the energy input into the gel whichcan vary with the direction of gravity.

In FIGS. 4-7, a cap 90 includes a gel pad 92 with a plurality ofgas-filled pockets 94. The pockets 94 may be formed by the presence oflightweight foam or balloons, or by casting or molding the gel aroundspheres or solid objects of other shapes that are removed after the gelpad 92 has cured The foam, balloons, spheres or other shapes may beinserted into the mold cavity either prior to or after filling the moldcavity with the slurry. In one aspect, the arrangement of gas-pockets 94substantially around the center of the gel pad 92 reduces the weight ofthe gel pad and resistance to the passage of a surgeon's hand orinstruments while retaining occlusive properties. An alternative aspectof the gel pad 92 contemplates a more random dispersion of gas pockets94 throughout the region beyond the center of the gel pad, which reducesthe overall weight of the gel pad.

The gel pad or gelcap in various aspects of the present invention may begamma sterilized The relative or comparative simplicity of qualifyingthe sterilization process, for example of gamma versus ethylene oxide,of the gel pad and the device with the gel pad is desirable. However,under gamma sterilization large bubbles can form in the gel pad causingpotential cosmetic or aesthetic issues in the sterilized devices. Thebubbles are more than 99% room air, so removal of the dissolved air inthe slurry is performed prior to forming the slurry into gel. Forexample, the slurry may be degassed via vacuum, as described above, andturned into gel by heat. Bubbles may still form in the gel during gammasterilization but disappear in a period of about 24 to 72 hours. In oneaspect, the percentage of dissolved gas in the mineral oil at roomtemperature is about 10%. The removal of the air in the gel has anadditional effect of making the gel firmer. This however iscounterbalanced by the softening effect on the gel caused by gammaradiation during gamma sterilization.

If the gel pad is to be gamma sterilized, the gel may include about 90%mineral oil by weight and about 10% KRATON by weight. As stated above,degassing the slurry has the effect of making the gel firmer However,the gamma radiation softens the gel to substantially the same firmnessas a gel having about 90% mineral oil by weight and about 10% KRATON byweight that is not degassed and gamma sterilized.

In one aspect, cyanoacrylate, e.g., SUPERGLUE or KRAZY GLUE, may be usedto bond or otherwise couple or attach the gel pad 60 to the cap 54. Theglue may attach to either the rubber or styrene component of thetri-block and the bond is frequently stronger than the gel materialitself In another aspect, a solvent may be used to dissolve the plasticsin the cap and the polystyrene in the gel. The solution of solvent isapplied to the gel pad and cap in either a spray or dip form. In effect,the solution melts both the plastic of the cap as well as thepolystyrene in the gel pad to allow a chemical bond to form between thetwo, which remains when the solvent evaporates.

Polyethylene can be dissolved in mineral oil and then applied to the gelpad. The mineral oil will not evaporate but will over time absorb intothe gel pad and impart a polyethylene layer on the gel pad that may havesome beneficial properties.

In one aspect, the gel pad 60 is cast into a DYNAFLEX or KRATON polymersupport structure, e g., the cap 54 By using KRATON polymer or a similarmaterial in the cap, ring adhesion between the gel pad 60 and the cap 54can be achieved. The polystyrene in the gel is identified as achievingadhesion with polyphenylene oxide (PPO), polystyrene and other polymers.

In the casting process the gel pad 60 and the cap 54 are heated to atemperature above about 130° C. and held at that temperature for severalhours, e.g., about 3 to 4 hours. The temperature used is not sufficientto deform the cap 54.

The cap 54, in one aspect, includes a polymer, e.g., polyethylene (PE).In one aspect, the polyethylene is a low density polyethylene (LDPE) orhigh density polyethylene (HDPE), or ultra high molecular weightpolyethylene (UHMWPE). In one aspect, the cap 54 may be made of apolymer, such as polycarbonate and may be fabricated by methodsincluding injection molding.

The gel includes mineral oil. PE has a higher molecular weight thanmineral oil. PE is dissolved by mineral oil at high temperatures. Assuch, as the PE and the mineral oil in the gel pad 60 intermix as bothare heated to and held at temperatures above about 130° C., a bondbetween the PE and gel pad is formed.

In one aspect, the cap 54 includes polycarbonate The polycarbonate ofthe cap 54 does not form bonds with the gel pad 60 at 130° C. However,by raising the temperature to about 150° C. for a few minutes duringcasting, bonding occurs between the gel pad 60 and the cap 54. As such,heating the gel pad 60 and cap 54 to temperatures at which both thepolystyrene of the gel and the polycarbonate are simultaneously beyondtheir melt points allow bonds to form between the gel pad and the cap.Alternatively, the gel pad 60 and cap 54 may be heated to near or at theglass transition temperature of the polycarbonate cap to form the bondbetween the gel pad and the cap.

Referring to FIGS. 8-10, the cap 100, 130 includes at least one gap 101,132 along the annular perimeter of the cap. The at least one gap 101,132 creates at least one first end 103, 134 and at least one second end105, 138 of the cap 100, 130. The gap 101, 132 facilitates a transitionin the cap from a first, larger periphery to a second, smallerperiphery. As will be discussed in more detail below, the cap 100, 130includes means for maintaining the cap at the second, smaller periphery.When the cap 100, 130 is set at the first, larger periphery, theretainer 52 (FIG. 1) may be inserted into or removed from the opening ofthe cap The retainer 52 (FIG. 1) may be fixedly coupled to the cap 100,130 by transitioning the perimeter of the cap to the second, smallerperiphery while the retainer is positioned within the opening of thecap, and maintaining the periphery of the cap at the second, smallerperiphery with the maintaining means.

Referring to FIGS. 8-9, the cap 100 incorporates squeeze release buckles102 molded into or otherwise coupled to the cap The cap 100 includes afirst arc 108 and a second arc 110, the first and second arcs beingseparated by first and second gaps 101 The first arc 108 has a firstbarbed portion 112 extending from a first end and adapted to be insertedin a snap fit mating relationship with a second, receiver portion 114extending from a second end of the second arc 110, thereby coupling theat least one first end 103 of the cap 100 to the at least one second end105 of the cap. Another barbed portion 112 may extend from the first endof the second arc 110, which is operationally inserted in a snap fitmating relationship with another receiver portion 114 extending from thesecond end 105 of the first arc 108. In another aspect, the first arc108 has a barbed portion 112 on each end of the arc with the second arc110 having corresponding receiver portions 114 on each end of the secondarc.

With the first and second arcs 108, 110 placed adjacent to each other,such that the first end 103 of the first arc corresponds with the secondend 105 of the second arc and the second end 105 of the first arccorresponds with the first end 103 of the second arc, and prior to beingsnapped together, the arcs define a first, larger periphery to allowplacement of a retainer 52 (FIG. 1) between the two arcs. The barbedportions 112 engage with corresponding receivers 114 coupling the arcstogether. Each barbed portion has a plurality of resilient arms 122, twoof which have projections 124 extending therefrom. Each receiver 114 hascorresponding sidewalls 126 for engaging projections 124 from the barbedportion, which causes the arms 122 to flex towards each other as thearms slide into a channel 128 defined by the receiver As the projections124 clear the ends of the sidewalls 126, the arms 122 are allowed toflex away from each other. Engagement or contact between the edges ofthe projections 124 with edges of the end of the sidewall 126 preventsthe arcs 108, 110 from being detached from each other. By coupling thetwo arcs 108, 110 together, the delimited circumference is reduced to asecond, smaller periphery to capture or hold the retainer 52 (FIG. 1).Flexing the arms 122 toward each other allows the barbed portions 112 todisengage from the sidewalls of the corresponding receiver 114 and toslide out from the receiver, thereby allowing the arcs 108, 110 toseparate and detach from the retainer 52 (FIG. 1).

Although not shown, additional barbed portions and receiver snapengagements may be included in each arc to assist in the couplingbetween the cap 100 and the retainer 52 (FIG. 1) or allow for other sizeand shape configurations of the cap and/or retainer. In one aspect, thecap 100 includes a single gap 101 and a single barbed portion 112 andreceiver portion 114 is provided. In one aspect the cap 100 having thesingle barbed portion 112 and receiver portion 114 may be provided witha hinge or pivot on another portion of the arc.

Referring now to FIG. 10, a cap 130 has a gap or opening 132 along aportion of the periphery of the cap A latch 136 is hinged or pivotallycoupled to the cap proximate a first end 134 of the opening 132 of thecap 130. Proximate a second, opposite end 138 of the opening 132, alatch receiver, such as an aperture or channel 140 defined bysubstantially parallel channel walls 142, 144, is configured toreleasably receive the latch 136. The latch 136 has a shaft 146 coupledto the cap 130 on one end and an enlarged or bulbous head 148 having aperimeter or diameter larger than the perimeter or diameter of the shafton the non-hinged end of the latch. The head 148 of the latch 136 isconfigured to be graspable and the latch swung so that the head mayengage and be held in the channel 140 defined by the channel walls 142,144. The width of the channel 140 is smaller than the diameter of thehead 148 of the latch 136 and the channel walls 142, 144 are resilientsuch that the walls flex away from each other during receipt of the headof the latch. Alternatively, or additionally, portions of the head 148may compress so that the head may be received and held in the channel140. In one aspect, one or more projections extend from one or bothchannel walls 142, 144 and engage notches in the head 148, or viceversa, to secure the latch 136 to the channel 140.

In this manner, with the latch 136 open or not engaged with the channel140, the initial periphery of the cap 130 allows simple placement of theretainer 52 (FIG. 1) within the periphery of the cap. Actuating thelatch 136 closes the cap 130 and reduces the size of the peripherydelimited by the cap, thereby securing the cap to the retainer 52(FIG.1).

Referring back to FIGS. 8-10, with the cap 100, 130 being separable orotherwise disjointed, placement of the respective retainer 52 (FIG. 1)within the inner periphery of the cap is eased. Subsequent joining orrecoupling of the cap together secures the retainer and cap to eachother. As such, one skilled in the art would recognize that other typesof couplings or engagements may be used to couple or join separateportions of the cap and/or the retainer together to close or delimit aperiphery to encase or otherwise secure the cap and the retainertogether and vice versa In one aspect, the retainer, or both theretainer and the cap, are separable, having couplings and/or engagementsto recouple the separate portions together to secure the cap andretainer to each other.

In FIGS. 11-12, the retainer 150 has one or more latches 152 toreleasably couple the retainer to a cap 54 (FIGS. 1 and 2) In oneaspect, a plurality of latches 152 is spaced along the periphery of theretainer 150. The latches 152 are hinged or pivotally coupled to theretainer 150 and are spaced along the periphery of the retainer. In oneaspect, each of the latches is coupled to the retainer 150 with a livehinge. In a first position, the latches 152 extend laterally from theperiphery of the retainer 150 in a substantially planar relationshipwith the retainer. Each latch 152 has a projection 156 extendingsubstantially orthogonally from the latch. After placing or fitting thecap 54 on the retainer 150 and/or vice versa, the latches 152 areactuated to couple the cap and retainer together. In particular, thelatches 152 are rotated toward the cap to a second position in which thelatches engage a portion or edge of the cap 54 to couple the retainer tothe cap. In one aspect, the engagement portion of the cap 54 is anopening, aperture, notch, step, projection or other similar type ofreceiver or engagement to secure the projection of the latch 152 to thecap.

In one aspect, one or more of the latches 152 has notches or openingsfor receiving corresponding projections or protrusions extendinglaterally from the cap 54 to couple the retainer 150 to the cap.Additionally or alternatively, although not shown, the cap may have oneor more latches hinged along the periphery of the cap for engagementwith portions or edges of the retainer to releasably couple the cap andretainer together.

Referring now to FIGS. 13-16, the retainer 160 has one or more resilientsnaps 162 for releasably coupling the retainer and a cap 164 together.The snaps 162 extend from the outer periphery or edge of the retainer160 in a substantially perpendicular direction from a substantiallyplanar, annular surface 166 of the retainer. The planar, annular surface166 of the retainer 160 secures the sleeve 56 (FIGS. 1 and 2) to theretainer. In one aspect, the surface 166 has projections or hooks tocatch and secure the sleeve 56 to the retainer 160 under tension Theedge of the retainer 160 is also slightly raised to assist in theholding of the sleeve 56 and the handling of the retainer.

Multiple snaps 162 may be spaced along the periphery of the retainer160. In one aspect, portions of the edge of the retainer 160 adjacent toeach snap are elevated, thereby forming sidewall portions 167 on eitherside of each snap The sidewall portions 167 protect the snaps 162 andstrengthen or bolster the coupling between the retainer 160 and the cap164 once coupled together Additionally, the sidewall portions 167facilitate handling and coupling the retainer 160 to the cap 164.Corresponding openings or cutouts 169 are disposed along the edges ofthe cap 164 to receive the sidewall portions 167 of the retainer 160.

Each snap 162 also has a projection 168 extending substantiallyperpendicular and radially inwardly from the snap. After placing orfitting a cap 164 on the retainer 160 and/or vice versa, both aresqueezed together. The snaps 162 are configured to flex or deflectradially outwardly to slide over a corresponding receiver portion 170,such as a lip portion or an edge, of the cap 164 when the cap andretainer are brought together in a mating relationship The snaps 162 arealso configured to return toward a neutral position after the projection168 on the snaps pass the receiver portion 170 of the cap 164 such thatthe projection of the snaps engages the receiver portion 170 of the cap.The receiver portion 170 in one aspect has an opening, aperture, notch,step, projection or other similar type of receiver or engagement meansto secure the projection 168 of the snap 162 to the cap 164Alternatively, one or more of the snaps 162 have notches or openings(not shown) for receiving corresponding projections or protrusions (notshown) extending from the cap to secure the snaps of the retainer 160 tothe cap 164. The cap 164 and retainer 160 may each be made via injectionmolding. Additionally, the cap 164 and retainer 160 may each be made ofa polycarbonate material.

In one aspect, as shown in FIGS. 17-20, a cap 180 has one or more snaps182 for releasably coupling the cap to a retainer 184. The snaps 182extend perpendicularly from the periphery of the cap 180 for engagementwith portions 188, such as corresponding lip portions, and/or edges ofthe retainer 184. Each snap 182 has a projection 186 extendingsubstantially perpendicular and radially inwardly from the snap. Afterplacing or fitting the cap 180 on the retainer 184, both are squeezedtogether. The snaps 182 flex or deflect radially outwardly to slide overthe lip or edge 188 of the retainer 184 when the cap 180 and retainerare brought together in a mating relationship, thereby securing the cap,retainer and sleeve 56 disposed therebetween. Each snap 182 isconfigured to return toward a neutral position after the projection 186on the snap passes the lip portion 188 of the retainer 184 such that theprojection of the snap engages the lip portion of the retainer.

Referring now to FIGS. 1-20, the retainers and caps previously describedin one aspect are rigid, thereby providing manufacturing benefits aswell as easing the assembly of the device. In one aspect, the caps 54,70, 90, 100, 130, 164, 180 also incorporate an inner cylindrical wall172 (see FIG. 14) to which the gel pad 60 is bonded or otherwise coupledor attached to the cap. In this manner, the gel pad 60 attaches to a“skeleton” inside the sleeve 56 and provides a sealing area between thedevice and the wound, incision and/or body cavity. The coupling orintersection of the sleeve, cap and retainer together also providesanother sealing area between the device and the body.

By securing the gel pad 60 to the inner cylindrical wall 172, thethickness of the gel pad and corresponding cap 54, 70, 90, 100, 130,164, 180 is minimized along with the overall footprint of the device Areduced thickness and overall size of the device provides a lighterdevice and allows for easier hand exchanges. With the gel pad thicknessreduced and the gel pad being able to be substantially flush or recessedin the cap, the “doming” phenomena produced by gas pressure exerted onthe body and device during insufflation is also reduced.

In various aspects (FIGS. 11-20) in accordance with the presentinvention, the retainer 150, 160 has a raised edge 158, 174 disposedaround the outer periphery of the retainer. A raised edge 159, 190, inone aspect, is also disposed around the inner periphery of the retainer150, 184 The inner periphery defines an opening 157, 192 through whichthe sleeve extends. The outer raised edge 158, 174 assists inmaintaining or securing the releasable coupling between the cap and theretainer. In one aspect, a groove 129 (FIG. 8) extends along thecircumference of the cap for receiving the outer raised edge to furtherenhance the coupling between the cap and retainer. Similarly, the innerraised edge assists in maintaining or securing the releasable couplingbetween the retainer and the sleeve. The inner raised edge alsofacilitates the seal between the inner cylindrical wall and/or gel pad,the sleeve and the retainer. In one aspect, notches or spaced valleys oropenings 155 (FIG. 11) are disposed along the inner raised edge 159,which facilitates the engagement of the inner cylindrical wall and/orgel pad with the retainer by reducing binding between the components.

Several of the above-described attachments could be modified tointegrate the retainer or a retainer like component directly into asleeve to which the cap is releasably coupled. Similarly, the cap may beintegrated directly into the retainer and/or sleeve creating anon-releasable coupling between the components.

In one aspect, casting the gel pad 60 into the cap 54 to form a gelcap66 includes placing the cap into a mold cavity of a casting mold. Themold cavity may include support for the annular walls of the cap 54. Themold may be made of aluminum, copper, brass, or other mold materialhaving good heat dissipation properties. However, those familiar withthe art will recognize that other mold materials having lower heatdissipation properties will produce acceptable parts and these arecontemplated as within the scope of the present invention as well.

The mold cavity having the cap 54 is filled with the slurry such thatthe slurry is in contact with the cap. To facilitate filling voids inthe mold cavity with the slurry, the slurry may be preheated, forexample, to about 52° C. (125° F.). Preheating the slurry to atemperature below the MGT reduces the viscosity of the slurry and allowsthe slurry to flow more easily. As stated above, the slurry may havebeen degassed in a vacuum. The slurry may be degassed again within themold after the mold cavity is filled to remove air that may have beenintroduced during the filling of the mold cavity and to facilitate flowof the slurry into voids in the mold. Heat is applied to the mold havingthe cap 54 and the slurry, such as in an oven, until the slurry attainsa temperature of about 150° C. As stated above, the slurry turns intogel at about 120° C., however, at about 150° C., the gel can bond to apolycarbonate cap 54. Depending on the material used to fabricate thecap 54, bonding may take place at temperatures other than about 150° C.If the cap 54 is fabricated of a material having a lower melting pointthan 120° C., then the gel pad 60, such as a gel slug 60, may be moldedseparately and then bonded to the cap. The slits 62, 64 may be moldedinto the gel pad 60 through the use of an insert in the form of the slitin the mold.

Once the temperature of the gel pad 60 reaches about 150° C., the gelcap66 may be cooled, such as by air-cooling, cold-water immersion, or othercooling means that are well known in the art. At 150° C. the gel pad issoft and if it were distorted during cooling it would set with thedistortion included To reduce the likelihood of distorting the gel pad60, the gelcap 66 may be cooled within the mold. Cooling times may varybased on parameters including size and configuration of the mold,quantity of gel, temperature and quantity of cooling medium, coolingmedium properties and the mold material. As an example, the cooling timemay be about two (2) hours if cooling in air and about fifteen (15)minutes if cooling in water. Whether cooling with air or water, thefinal properties of the gel are substantially the same. The gelcap 66 istypically cooled to about ambient room temperature, but may be cooled tolower temperatures. If the gelcap 66 is cooled to the freezing point ofthe gel, about 0° C., then the gel will freeze and become hard. This maybe beneficial for other means of coupling the gel pad 60 to the cap 54,such as with a secondary operation. The gelcap 66 may be removed fromthe mold at any time after the gel has set.

When removed from the mold, the gel pad 60 typically has a tackysurface. The gelcap 66 may be coated with a powder, such as cornstarch,to substantially reduce or eliminate the tackiness of the cured gel pad60.

As stated above, in another aspect, the gel pad 60 may be moldedseparately from the cap 54 and coupled to the cap 54 by a secondaryoperation, such as by bonding. In one aspect, the gel pad 60 may bemolded into a gel slug 60 having an outer perimeter smaller than theinner cylindrical wall of the cap 54 and to a height higher that theheight of the cap. Since the gel pad 60 is being molded separate fromthe cap 54, the slurry only needs to be heated until it reaches about120° C. and completes the transformation from slurry into gel and thegel becomes substantially transparent. The gel slug 60 may then beplaced within the inner cylindrical wall of the cap 54 The gel slug 60may be cooled and/or frozen prior to placing it within the innercylindrical wall of the cap 54. The gel slug 60 may be coupled to thecap 54 through compression molding with the gel slug being compressedlongitudinally so that the outer perimeter of the gel slug expands andcompresses against the inner cylindrical wall of the cap The gel slug 60and cap 54 are heated to a sufficient temperature for the polystyrene ofthe gel and the polymer of the cap to form bonds between the gel and thecap. Molding the gel slug 60 separately from the cap 54 and heat bondingthe gel slug to the cap at a later time is especially useful when thecap is made of a material that has a lower melting temperature than theMGT. In such situations, the gel slug 60 can be molded first and heatbonded to the cap 54 without melting the cap.

In reference to FIGS. 21-22, a cap 54 has the gel pad 60 attached,formed or integrated with the cap and is capable of being coupled to theretainer 52 which is capable of being coupled to the sleeve 56. In oneaspect, the elongate sleeve 56 extends through an incision and isattached to a retention ring 58 that contacts the interior portions ofthe body cavity and provides tension between the retainer 52 outside thebody cavity and the deformable retention ring. A plurality ofstabilizers 200-206 extends from the retention ring 58 to the gel pad60.

In one aspect, the stabilizers 200-206 are sized and configured toprevent excessive bulging of the gel pad 60 in response to the elevatedbody-cavity pressure. The stabilizers 200, 202, in one aspect, include aplurality of strings or tethers that extend from the retention ring 58and subsequently through or into the gel pad 60. The stabilizers 204,206 include a plurality of contiguous gel based gussets or webs thatextend between the retention ring 58 and the gel pad 60.

With reference to FIGS. 23-24, a cap 54 has a woven or knitted fabric210 that is stretchable and/or resilient. The fabric 210 is integratedinto or attached onto the surface 211 of the gel pad 60 and coupled tothe periphery of the cap 54. The fabric 210 provides support tocounteract the “doming” or “bowing” of the gel pad 60 or cap 54 underthe influence of the internal inflation gas pressure associated with theinflation of the body cavity. In one aspect, a first fabric 212 can beintegrated on a first surface 214 of the gel pad 60 and coupled to theperiphery of the cap 54 and a second fabric 216 can be integrated on asecond, opposite surface 218 and coupled to the cap. In this manner,counteracting support is provided in both directions to minimizeuncontrolled deformation of the gel pad as a hand or instrument isplaced through or withdrawn.

In FIG. 25, a first fabric 220 is coupled to the periphery of the cap 54and a second fabric 222 is coupled to the cap a distance from the firstfabric. A cavity 224 is defined by the space between the first fabric220 and the second fabric 222. The gel pad 60 may be inserted into thecavity 224 or otherwise held within the cavity. The gel pad 60 may beprocessed alone and formed to a preferred shape and size and firmnessprior to coupling to the cap 54. The temperatures commonly required toprocess SEBS may substantially deform associated plastic structures.Therefore, separate processing and subsequent assembly may be useful forconstructing a cap with the gel pad.

Referring to FIG. 26, the gel pad 60 has multi-cusped lobes 230 thatseal upon one another. The channel 232 through which a surgeon's hand orinstruments may be inserted through is formed between individual lobesof the gel pad 60.

Accordingly, the present invention provides a hand access device andmethods thereof. Although this invention has been described in certainspecific embodiments, many additional modifications and variations wouldbe apparent to those skilled in the art. It is therefore to beunderstood that this invention may be practiced otherwise thanspecifically described, including various changes in the size, shape andmaterials, without departing from the scope and spirit of the presentinvention. Thus, embodiments of the present invention should beconsidered in all respects as illustrative and not restrictive. Thescope of the present invention is to be determined by the appendedclaims and their equivalents rather than the foregoing description.

1. A method of making a gelcap, comprising: providing an annular caphaving an opening therethrough; providing a casting mold having a moldcavity; providing a solvent; providing a polymer ofstyrene-ethylene/butylene-styrene having a styrene to rubber ratio of33/67; mixing the solvent and polymer to form a slurry of about 90% byweight solvent and about 10% by weight polymer; degassing the slurry ina vacuum chamber; filling the mold cavity with slurry; heating theslurry and the mold until the slurry attains a temperature within arange between about 130° C. and about 250° C. and maintaining the moldand slurry within the range until the slurry transforms into gel;cooling the gel to about ambient room temperature; and removing thecured gel from the mold.
 2. The method of claim 1, the providing asolvent step including providing mineral oil.
 3. The method of claim 1Ithe degassing step including applying a vacuum of about 0.79 meter ofmercury to the slurry.
 4. The method of claim 1, the degassing stepincluding stirring the slurry while degassing the slurry.
 5. The methodof claim 1, further comprising degassing the slurry while the slurry isin the mold.
 6. The method of claim 1, further comprising preheating theslurry prior to filling the mold cavity with slurry.
 7. The method ofclaim 1, the cooling step including immersing the gel in water.
 8. Themethod of claim 1, the cooling step including air cooling the gel. 9.The method of claim 1, further comprising inserting a plurality ofgas-filled balloons into the slurry in the mold cavity.
 10. The methodof claim 9, the inserting step including inserting the balloons into theslurry substantially around the center of the mold cavity.
 11. Themethod of claim 9, the inserting step including dispersing the balloonsin the slurry randomly about the mold cavity throughout the regionbeyond the center of the mold cavity.
 12. The method of claim 1, furthercomprising: inserting a plurality of solid objects into the slurry inthe mold cavity; and removing the plurality of solid objects after thegel is cured.
 13. The method of claim 12, the inserting step includinginserting spheres into the slurry around the center of the mold cavity.14. The method of claim 12, the inserting step including inserting thesolid objects in the slurry substantially around the center of the moldcavity.
 15. The method of claim 12, the inserting step includingdispersing the solid objects in the slurry randomly about the moldcavity throughout the region beyond the center of the mold cavity. 16.The method of claim 1, further comprising sterilizing the gelcap withgamma sterilization.
 17. The method of claim 1, further comprisingmixing the slurry in a centrifuge while heating the slurry and the mold.18. The method of claim 1, further comprising coupling the gel to thecap.
 19. The method of claim 18, the coupling step including bonding thegel to the cap with cyanoacrylate.
 20. The method of claim 18, theproviding a cap step including providing a cap made of a plasticmaterial.
 21. The method of claim 20, the coupling step including:applying a solvent to the gel to melt the polystyrene in the gel;applying a solvent to the cap to melt the plastic of the cap; andplacing the gel in contact with the cap to allow a chemical bond to formbetween the gel and the cap.
 22. The method of claim 18, wherein: theproviding a cap step including providing a cap having an innercylindrical wall, the opening of the cap being defined by the innercylindrical wall, the cap being made of a polymeric material; and thecoupling step including coupling the cured gel to the inner cylindricalwall of the cap.
 23. The method of claim 22, the providing a castingmold step including providing a mold configured to produce a gel slughaving a smaller periphery than the inner cylindrical wall of the capand a height higher than the height of the inner cylindrical wall of thecap.
 24. The method of claim 23, further comprising placing the gel slugwithin the inner cylindrical wall of the cap.
 25. The method of claim24, the coupling step including compression molding the gel slug to theinner cylindrical wall of the cap.
 26. The method of claim 24, thecoupling step including heating the gel slug and the cap to atemperature sufficient for the polystyrene of the gel and the polymer ofthe cap to form bonds.
 27. The method of claim 1, further comprising:placing the cap into the mold cavity, wherein the filling step includingfilling the mold cavity having the cap with slurry such that the slurryis in contact with the cap, the heating step including heating theslurry, the cap and the mold until the slurry transforms into gel, thegel being coupled to the cap, thereby forming a gelcap, the cooling stepincluding cooling the gelcap, and the removing step including removingthe gelcap from the mold.
 28. The method of claim 27, wherein: theproviding a cap step including providing a cap includingstyrene-ethylene/butylene-styrene; and the heating step includingheating the slurry, cap and mold to above about 130° C. and maintainingthe temperature above about 130° C. until a bond is formed between thecap and mold.
 29. The method of claim 27, wherein: the providing a capstep including providing a cap including polycarbonate; and the heatingstep including heating the slurry, cap and mold to about 150° C. andmaintaining that temperature until a bond is formed between the cap andmold.
 30. A method of making a gelcap, comprising: providing an annularcap having an opening therethrough; providing a casting mold having amold cavity; providing mineral oil; providing a polymer ofstyrene-ethylene/butylene-styrene having a styrene to rubber ratio of33/67; mixing the solvent and polymer to form a slurry of about 90% byweight solvent and about 10% by weight polymer; degassing the slurry ina vacuum chamber by stirring the slurry and applying a vacuum of about0.79 meter of mercury to the slurry; preheating the slurry prior tofilling the mold cavity with slurry; filling the mold cavity withslurry; heating the slurry and the mold until the slurry attains atemperature within a range between about 130° C. and about 250° C. andmaintaining the mold and slurry within the range until the slurrytransforms into gel; degassing the slurry further while the slurry is inthe mold; cooling the gel to about ambient room temperature; removingthe cured gel from the mold; and coupling the gel to the cap, therebyforming the gelcap.
 31. The method of claim 30, the coupling stepincluding bonding the gel to the cap with cyanoacrylate.
 32. The methodof claim 30, wherein: the providing a cap step including providing a capmade of a plastic material; and the coupling step including applying asolvent to the gel to melt the polystyrene in the gel, applying asolvent to the cap to melt the plastic of the cap, and placing the gelin contact with the cap to allow a chemical bond to form between the geland the cap.
 33. The method of claim 30, wherein: the providing a capstep including providing a cap having an inner cylindrical wall, theopening of the cap being defined by the inner cylindrical wall, the capbeing made of a polymeric material; the providing a casting mold stepincluding providing a mold configured to produce a gel slug having asmaller periphery than the inner cylindrical wall of the cap and aheight higher than the height of the inner cylindrical wall of the cap;and the coupling step including coupling the cured gel to the innercylindrical wall of the cap.
 34. The method of claim 33, furthercomprising placing the gel slug within the inner cylindrical wall of thecap.
 35. The method of claim 34, the coupling step including compressionmolding the gel slug to the inner cylindrical wall of the cap.
 36. Themethod of claim 34, the coupling step including heating the gel slug andthe cap to a temperature sufficient for the polystyrene of the gel andthe polymer of the cap to form bonds.
 37. A method of making a gelcap,comprising: providing an annular cap having an opening therethrough;providing a casting mold having a mold cavity; providing mineral oil;providing a polymer of styrene-ethylene/butylene-styrene having astyrene to rubber ratio of 33/67; mixing the solvent and polymer to forma slurry of about 90% by weight solvent and about 10% by weight polymer;degassing the slurry in a vacuum chamber by stirring the slurry andapplying a vacuum of about 0.79 meter of mercury to the slurry;preheating the slurry prior to filling the mold cavity with slurry;placing the cap into the mold cavity; filling the mold cavity having thecap with slurry such that the slurry is in contact with the cap; heatingthe slurry, the cap and the mold until the slurry attains a temperaturewithin a range between about 130° C. and about 250° C. and maintainingthe mold and slurry within the range until the slurry transforms intogel, the gel being coupled to the cap and forming a gelcap; degassingthe slurry further while the slurry and the cap are in the mold; coolingthe gelcap to about ambient room temperature; and removing the gelcapfrom the mold.
 38. The method of claim 37, wherein: the providing a capstep including providing a cap includingstyrene-ethylene/butylene-styrene; and the heating step includingheating the slurry, cap and mold to above about 130° C. and maintainingthe temperature above about 130° C. until a bond is formed between thecap and mold.
 39. The method of claim 37, wherein: the providing a capstep including providing a cap including polycarbonate; and the heatingstep including heating the slurry, cap and mold to about 150° C. andmaintaining that temperature until a bond is formed between the cap andmold.